Rotation adapter and receiver for minimally invasive surgical devices

ABSTRACT

A rotation adapter for a minimally invasive surgical apparatus is disclosed. The rotation adapter has a proximal journal and a distal journal. The rotation adapter also has a rotation index coupled between the proximal and distal journals. The rotation adapter further has an actuator input wherein the actuator input comprises a keyed slot and an effector output.

RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 15/980,776 filed May 16, 2018 and entitled “ROTATION ADAPTER ANDRECEIVER FOR MINIMALLY INVASIVE SURGICAL DEVICES”. This patentapplication claims priority to U.S. patent application Ser. No.15/242,073 filed Aug. 19, 2016 and entitled “ROTATION ADAPTER ANDRECEIVER FOR MINIMALLY INVASIVE SURGICAL DEVICES”. U.S. patentapplication Ser. No. 15/242,073 is a continuation-in-part of U.S. patentapplication Ser. No. 14/325,824 filed Jul. 8, 2014 and entitled“CRIMPING INSTRUMENT WITH REDUCED DIMENSION, CONTINUED COMPATIBILITY,AND TISSUE PROTECTION FEATURES”. This patent application also claimspriority to U.S. Provisional Patent Application No. 62/207,287 filedAug. 19, 2015 and entitled “ROTATION ADAPTER AND RECEIVER FOR MINIMALLYINVASIVE SURGICAL DEVICES”. The Ser. No. 15/242,073, 14/325,824 and62/207,287 applications are hereby incorporated by reference in theirentirety.

FIELD

The claimed invention relates generally to minimally invasive surgicalinstruments, and more particularly to a rotation adapter and receiverwhich enable effective rotation of an end effector on such minimallyinvasive surgical devices.

BACKGROUND

Malleable suture fasteners such as the sleeves sold under the trademarksTi-KNOT® and COR-KNOT® by LSI Solutions, Inc. are a significantimprovement over hand or instrument-tied knots in laparoscopic surgicalprocedures. The sleeves, which are made of a malleable material that hasproven safe with prolonged exposure to body tissue, are slid over two ormore strands of suture and deformed or crimped to secure the strands ofsuture.

An exemplary crimping instrument is shown in U.S. Pat. No. 7,235,086,entitled “CRIMPING INSTRUMENT WITH MOTION LIMITING FEATURE”, assigned toLSI Solutions, Inc., of Victor, N.Y. FIG. 1 illustrates such a crimpingdevice 20, having a handle 22 with an actuator 24 that is movablerelative to the handle 22. A hollow shaft 26 extends from the handle 22to a distal end 28 of the shaft 26. The distal end 28 of the shaft 26can be seen more clearly in the partial cross-sectional view of FIG. 1A.

Suture ends 30 can be threaded through a crimping sleeve 32 held betweena hammer 34 and an anvil 36. The suture ends 30 pass out a hole in theside of the shaft 26, and the device can be used to position thecrimping sleeve 32 at a desired location on the suture 31 relative to asurface 38 through which the suture 31 has been secured (for example,tissue, a replacement anatomical structure such as a heart valve, or anaugmentive anatomical structure such as a heart valve annulus).

Squeezing the actuator 24 towards the handle 22 causes a wedge 40,located in the shaft 26, to advance and to force the hammer 34 into thecrimping sleeve 32. The hammer 34 crimps the crimping sleeve 32 againstthe anvil 36, and the suture 31 is held tightly by the deformed sleeve32. A blade 42 may also be incorporated within the shaft 26 and can besimultaneously moveable by the actuator 24 in order to trim the sutureends 30.

Such instruments for attaching suture fasteners 32 have proven to bevery effective. The Ti-KNOT® and COR-KNOT® devices from LSI Solutions,Inc. (information available at www.lsisolutions.com) have been widelyaccepted by surgeons for the recognized benefits of time savings, easeof use, and reliability. (See, for example, “New Knot Tying Techniquefor Minimally Invasive Approach to Mitral Valve Repair”, an abstract byRodriguez, Sutter, and Ferdinand presented at the AATS 2011 MitralConclave in New York, N.Y. in 2011 or “Use of Automatic Knot-Tying andCutting Device is Shortening Aortic Cross-Clamp Times in MinimallyInvasive Mitral Valve Surgery”, an abstract by Gersak and Robicpresented at the 26th Annual EACTS Meeting in Barcelona, Spain in 2012.)

Devices like the COR-KNOT® device enable many types of minimallyinvasive surgery (MIS), or, more specifically, minimally invasivecardiac surgery (MICS). MIS is a type of surgery performed through oneor more small incisions or access sites created in a patient. MIS hasbeen shown to have at least equivalent morbidity and mortality outcomesas compared to conventional approaches, with reported advantages ofreduced postsurgical pain, better respiratory function, shorter hospitalstay, and improved cosmesis. Such advantages are increased with eversmaller sized MIS access points. As a result, it is very desirable tohave smaller and smaller MIS tools which can enable the use of suchsmaller MIS access points. In other MIS approaches, specifically, forexample MICS for aortic valve replacement, a smaller device tip,especially with more rounded edges, would be easier to position remotelyand would reduce the potential for device-related tissue trauma and/orprosthetic damage.

The outside of the prosthetic valve shall be close in size to the spaceavailable at the aortic root. The larger a replacement aortic valve'sblood passage area is relative to the opening in the outflow track ofthe left ventricle, the more blood can pass through without flowdisturbances. After removing the diseased native valve, it is thereforedesirable to install a replacement prosthetic valve with the largestpossible diameter into the aortic root. Replacement heart valves usuallyhave a sewing ring attached to and just peripheral to the valve leaflet.This ring is typically several millimeters wide, is designed to besutured to the aortic root, and can then be secured in place withmechanical knots. Given the narrow space available over the sewing ringbetween the valve leaflets and the aortic root, a mechanical knotdelivery device about the same size as the radial width of a sewing ringis desired. A narrower MICS device tip would enable less challengingplacement of the mechanical knot into this narrow space as well aseasier device tip positioning and removal. A narrow device tip can alsoenable the use of larger diameter valves for improved blood flow.

Unfortunately, it is not a simple matter to reduce the size of all ofthe components in a device such as the current COR-KNOT® device becausesuch changes could also impact the size (and therefore the operatingproperties) of the mechanical crimping sleeve 32. Devices such as theCOR-KNOT® device are always put through rigorous testing andqualification procedures, both internally with the manufacturer andexternally, such as when obtaining Food and Drug Administration (FDA)and European Community (CE mark) clearance. Currently, the outsidediameter of the COR-KNOT® device shaft 26 is approximately two-hundredthousandths of an inch. The inside diameter of the shaft 26 isapproximately one hundred seventy-six thousandths of an inch, while thetitanium sleeve 32 has an outside diameter of approximately forty-ninethousandths of an inch. Subtracting the room needed for the sleeve 32within the shaft 26, this means that the current COR-KNOT® device onlyhas about one hundred twenty-seven thousandths of an inch to accommodatethe hammer 34, anvil 36, travel space for the wedge 40, and variousassociated tolerances. Reducing the size of the crimpable sleeve to gainmore room in a smaller shaft could potentially require a different sizecrimpable sleeve. The current sleeve has been very successfully used inover 250,000 patients throughout the world. This sleeve size has provencompletely reliable and useful with a broad range of common surgicalsutures; no failures have been reported after securing over 1.8 millionsutures. This sleeve size is remarkably effective and well-received;changing its dimensions or configuration would have the potential torender it less efficacious. Likewise, it would be unwise to change theoperating features of the hammer 34 and anvil 36 which impart thereliable crimped configuration for the proven suture sleeve 32. Still,it would be desirable to have a crimping device 20 with smaller shaft 26dimensions in order to enable use with ever smaller MIS access pointsand in MICS applications.

Therefore, there is a need for a surgical crimping instrument havingsmaller dimensions when compared to the currently available devices,which are already quite small. Furthermore, there is a need for such areduced dimension surgical crimping instrument to have continuedcompatibility with existing uncrimped sleeves for loading and crimpingthem to an identical configuration to ensure the continuation ofreliability and performance from such proven sleeves. There is a needfor such devices to place a premium on patient safety, so it would alsobe desirable for this surgical crimping instrument to have even furtherenhanced tissue protection features. Finally, it is highly desirable forthe minimally invasive surgical apparatuses of all types (including, butnot limited to, surgical crimping instruments and surgical suturingdevices) to have an ability for the end effector to rotate independentlyfrom the handle/actuator so that more ergonomic and flexible use ispossible for surgeons.

SUMMARY

A rotation adapter for a minimally invasive surgical apparatus isdisclosed. The rotation adapter has a proximal journal and a distaljournal. The rotation adapter also has a rotation index coupled betweenthe proximal and distal journals. The rotation adapter further has anactuator input and an effector output.

A rotation adapter receiver for a minimally invasive surgical apparatusis also disclosed. The rotation adapter receiver has opposing beams anda proximal bushing coupled between the opposing beams. The rotationadapter receiver also has a distal bushing coupled between the opposingbeams. The rotation adapter receiver further has a rotation constraintcoupled between the opposing beams and positioned between the proximaland distal bushings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a prior art surgical crimping instrument for crimpinga suture fastener to one or more sutures.

FIG. 1A shows an enlarged partial cross-sectional view of the distal endof the shaft of the prior art surgical crimping instrument of FIG. 1.

FIG. 2 illustrates, in cross-sectional view, the distal end of a newembodiment of an instrument for crimping a suture fastener to a surgicalsuture, the instrument enabling reduced dimensions when compared to theprior art while being backwards compatible with existing, FDA approvedcrimpable sleeves. A crimpable sleeve is not yet installed in theinstrument shown in FIG. 2.

FIG. 2A shows an enlarged cross-sectional view of the distal end of theshaft of the instrument from FIG. 2.

FIG. 3 illustrates, in cross-sectional view, the distal end of theinstrument for crimping a suture fastener from FIG. 2 with a crimpablesleeve installed in one embodiment of an expanded receiving face.

FIG. 3A shows an enlarged cross-sectional view of the expanded receivingface from the instrument embodiment shown in FIG. 3.

FIGS. 3B-3C are enlarged cross-sectional views of other embodiments ofan expanded receiving face for an instrument for crimping a suturefastener.

FIG. 4 is a partially schematic, exploded perspective view of oneembodiment of an instrument for crimping a suture fastener.

FIG. 5 is a perspective view of one embodiment of a crimping memberhaving a hammer, an anvil, and an expanded receiving face.

FIG. 6 is a perspective view of one embodiment of a pusher configured toengage a hammer. In this embodiment, a suture cutting blade is coupledto the pusher.

FIG. 7 is a partial cross-sectional side view of the embodied instrumentfor crimping a suture fastener from FIG. 2 with suture ends passedthrough a crimpable sleeve on one end of the instrument and exitingthrough a slot in the bottom of the instrument.

FIG. 7A is a bottom view of the embodied instrument for crimping asuture fastener from FIG. 7.

FIG. 8 is a partial cross-sectional side view of the embodied instrumentfor crimping a suture fastener from FIG. 7 with a pusher advanced to afirst position where the hammer is forced down onto the crimpablesleeve, towards the anvil, resulting in a suture holding crimp beingformed in the crimpable sleeve.

FIG. 8A is a cross-sectional view taken along line 8A-8A from FIG. 8,looking down the device shaft, and illustrating one embodiment of ablade steering guide formed in the anvil of the instrument for crimpinga suture fastener.

FIG. 9 is a cross-sectional side view of the embodied instrument forcrimping a suture fastener from FIG. 8 with the pusher advanced to asecond position where a blade coupled to the pusher is cutting the freesuture ends protruding from the crimpable sleeve.

FIGS. 10A-10J illustrate different crimping members having a variety offlexure embodiments.

FIG. 11 is a partially exposed perspective view of one embodiment of aninstrument having a rotatable shaft for crimping a suture fastener.

FIG. 11A is a side cross-sectional view of the instrument for crimping asuture fastener from FIG. 11.

FIG. 11B is a cross-sectional view of the instrument for crimping asuture fastener from FIG. 11A taken along line 11B-11B.

FIGS. 12A and 12B illustrate one embodiment of a proximal bushing inboth closed and open configurations, respectively.

FIG. 13 illustrates one embodiment of a distal bushing.

FIGS. 14A and 14B illustrate one embodiment of a rotation constraint inboth closed and open configurations, respectively.

FIG. 15 is a partially exposed perspective view of one embodiment of aminimally invasive surgical device having a rotation adapter supportedby the proximal bushing of FIG. 12A and the distal bushing of FIG. 13.

FIGS. 16A and 16B illustrate one embodiment of a rotation adapterreceiver in assembled and disassembled forms, respectively.

FIG. 17 is a partially exposed perspective view of one embodiment of aminimally invasive surgical suturing device having a rotation adaptersupported by the rotation adapter receiver of FIG. 16A.

FIGS. 18A and 18B illustrate another embodiment of a rotation adapterreceiver in assembled and disassembled forms, respectively.

FIG. 19 is a partially exposed perspective view of another embodiment ofa minimally invasive surgical suturing device having a rotation adaptersupported by the rotation adapter receiver of FIG. 18A.

FIGS. 20A and 20B illustrate a further embodiment of a rotation adapterreceiver in assembled and disassembled forms, respectively.

FIG. 21 is a partially exposed perspective view of a further embodimentof a minimally invasive surgical suturing device having a rotationadapter supported by the rotation adapter receiver of FIG. 20A.

FIGS. 22A and 22B illustrate a schematic cross-sectional view of arotation constraint interacting with a rotation index in both a restingstate and a transitory state between two resting positions,respectively.

FIG. 23 illustrates stresses on a rotation adapter receiver and showshow the stresses are, in part, alleviated by a beam of the rotationadapter receiver.

FIG. 24 illustrates one embodiment of a rotation adapter for use with aminimally invasive surgical apparatus for applying surgical knots.

FIG. 25 is an exploded view of a portion of a minimally invasivesurgical apparatus for applying surgical knots and having the rotationadapter of FIG. 24.

FIG. 26 illustrates one embodiment of a rotation adapter for use with aminimally invasive surgical suturing device.

FIG. 27 is an exploded view of a portion of a minimally invasivesurgical suturing device and having the rotation adapter of FIG. 26.

FIG. 28 is an assembled perspective view of the rotation adapterreceiver 230 and the rotation adapter 284 from FIG. 27.

FIGS. 29A-29G illustrate an example of a suturing device having arotation adapter being used to place a suture stitch into tissue.

FIGS. 30A-30B illustrate different embodiments of suture managementfeatures on a minimally invasive surgical suturing device having arotation adapter.

FIG. 31 illustrates a further embodiment of a suture management featurefor a direction indicator of a rotation adapter.

It will be appreciated that for purposes of clarity and where deemedappropriate, reference numerals have been repeated in the figures toindicate corresponding features, and that the various elements in thedrawings have not necessarily been drawn to scale in order to bettershow the features.

DETAILED DESCRIPTION

FIG. 2 illustrates, in cross-sectional view, the distal end 44 of oneembodiment of an instrument for crimping a suture fastener to a surgicalsuture. It should be understood that the term “suture”, as used herein,is intended to cover any thread, cable, wire, filament, strand, line,yarn, gut, or similar structure, whether natural and/or synthetic, inmonofilament, composite filament, or multifilament form (whetherbraided, woven, twisted, or otherwise held together), as well asequivalents, substitutions, combinations, and pluralities thereof forsuch materials and structures. The distal end 44 includes a shaft 46which houses some of the instrument components, including a hammer 48,and anvil 50, and a pusher 52. The hammer 48 is movable relative to theanvil 50 for crimping a suture fastener 54 therebetween. In this view,the suture fastener 54 is not yet installed in the device. However, inlater views, the suture fastener 54 will be installed and the operationof the hammer 48 and the anvil 50 will be discussed in more detail.Generally, however, the pusher 52 is moveable in a directionsubstantially parallel to a longitudinal axis of the shaft 46 and isconfigured to engage at least one of the hammer 48 and the anvil 50 forurging the hammer 48 and anvil 50 together.

The crimping instrument also includes an expanded receiving face 56configured to receive the suture fastener 54. The expanded receivingface 56 can be seen in more detail in the enlarged cross-sectional viewof FIG. 2A. Unlike the prior art where the receiving face is flush withthe end of the shaft, in the claimed invention, the expanded receivingface 56 sticks out a longitudinal distance Di past the end of the shaft46. In some embodiments, the expanded receiving face 56 is also sized toreach beyond the inside diameter (ID) of the shaft 46 and outwardtowards, to, or beyond the outside diameter (OD). For example, theexpanded receiving face 56 in the embodiment of FIG. 2A expands radiallya distance Dz past the inner diameter (ID) towards the outside diameter(OD). Depending on the embodiment, a rounded edge 58 can be formed onthe expanded receiving face 56 at least partially within the expansiondistances Di and Dz. This rounded edge 58 of the expanded receiving face56 can provide one measure of tissue protection when the tip of theinstrument is brought into contact with a patient. This can beespecially important in light of the small dimensions involved in theconstruction of such a small minimally invasive device. In the prior artdevice, where the receiving face was flush with the end of the shaft,minimal corner rounding could be provided in the shaft due to thethinness of the shaft wall. As the size of the device is reduced, andthe shaft wall is potentially made even thinner, there is just notenough thickness in the wall for adequate rounding. The expandedreceiving face 56 provides a solution to this problem by allowing arounded surface 58 to be formed which can protect tissue from thepotentially sharp edges of the shaft 46.

Despite these advantages of the expanded receiving face 56, it was stillcounterintuitive to expand the receiving face from the previous designbecause it would have meant moving the position where the suturefastener is normally held out beyond a nominal position where the hammerand anvil could act properly on it when crimping. However, inembodiments such as the one illustrated in FIG. 2A, the expandedreceiving face 56 also has a collar recess 60, configured to hold acollar 62 of the suture fastener 54. With a collar recess 60, anexpanded receiving face 56 can be implemented while a desired positionof the suture fastener 54 can be maintained relative to the hammer 48and the anvil 50.

These are advantages which have been identified in the inventiveconcept, but it was still counter-intuitive that expanding the devicewould be a key to making it smaller. As it turns out, however, andwithout being limited to one particular theory, expanding the receivingface 56 as described above provides additional structural support to thehammer 48 and anvil 50 pieces which may be coupled directly orindirectly to the expanded receiving face 56. This additional supportfurther enables the reduction of outer hammer 48 and/or anvil 50material near where the hammer 48 and anvil 50 contact the shaft 46 andaway from the surfaces of the hammer 48 and anvil 50 which cometogether. This allows a smaller diameter shaft 46 to be used while stillmaintaining the ability to work with an existing size suture fastener 54and to impart the same crimping profiles into the suture fastener 54. Infact, use of the expanded receiving face 56 design has enabled thesuccessful manufacture and testing of crimping instruments with anoutside diameter of approximately 0.177 inches versus the previousoutside diameter of approximately 0.203 inches, a 12% reduction inoutside diameter while providing the exact same sized crimpable suturefastener. Other embodiments may show even greater size reductions, andall of these reductions may enable even smaller devices in remote,constrained surgical areas, thereby helping to improve patient outcomes.

FIG. 3 shows the distal end 44 of the instrument from FIG. 2 with acrimpable suture fastener 54 (crimpable sleeve) installed in the collarrecess 60 of the expanded receiving face 56. In this embodiment, thehammer 48 and the anvil 50 are part of a crimping member 64 which hasfirst and second opposed legs 66, 68. The hammer 48 is located near theend of the first opposed leg 66, while the anvil 50 is located near theend of the second opposed leg 68. The shaft 46 and the second leg 68define respective openings 70, 72 to allow suture ends (not shown here,but will be shown later) to pass from the collar 62, through and out ofthe other end of the suture fastener 54, between the first and secondopposing legs 66, 68, and then out through openings 70, 72 to an areaoutside of the shaft 46. In this embodiment, part of the suture fastener54 rests against the anvil 50, while the hammer 48 is positioned justabove the suture fastener 54. In other embodiments, the hammer 48 may beconfigured to be just touching or biased against the suture fastener 54to help hold it in place before crimping. Depending on the embodiment,this starting position of the hammer 48 can be influenced by theconfiguration of a flexure portion 74 in the first opposing leg 66.Different flexure 74 options will be discussed later in thisspecification.

FIG. 3A shows an enlarged cross-sectional view of the expanded receivingface 56 from the instrument embodiment shown in FIG. 3. For someembodiments, such as the one shown in FIG. 3A, the collar recess 60 is apartial recess in the sense that, despite the collar recess 60, aportion of the suture fastener's collar 62 still sticks out past the endof the expanded receiving face 56. In other embodiments, such as the oneillustrated in FIG. 3B, the collar recess 60B is a flush recess becausethe suture fastener's collar 62 is flush with the end of the alternateexpanded receiving face 56B. In still other embodiments, such as the oneillustrated in FIG. 3C, the collar recess 60C is an over-deep recessbecause the suture fastener's collar 62 is set below the end of thealternate expanded receiving face 56C.

Before discussing the operation of the instrument for crimping a suturefastener in more detail, it is helpful to understand how the parts ofthis device embodiment are assembled together. Accordingly, FIG. 4 is apartially schematic, exploded perspective view of one embodiment of aninstrument for crimping a suture fastener. The crimping member 64,discussed previously, can be inserted into the distal end 44 of theshaft 46. A recess 76 in the crimping member 64 can be pinned, staked,or otherwise held in place at a corresponding pinning location 78 in theshaft 46 in order to keep the crimping member 64 from coming out of theshaft 46. The pusher 52 can be coupled to or an extension of a push rod80. The push rod 80 may include a coupling feature 82 configured to becoupled to a handle/actuator 84. The actuator 84 can be any type ofmanually operated or automated device, such as, but not limited to alever, an arm, a knob, a slide, a motor, a solenoid, or any pluralityand/or combination thereof which can be used to slide the pusher 52 backand forth within the shaft 46 along a path which is substantiallyparallel to a longitudinal axis of the shaft 46. One suitable actuator84 is the handle and lever disclosed in U.S. Pat. No. 7,235,086 entitled“CRIMPING INSTRUMENT WITH MOTION LIMITING FEATURE”, the entirety ofwhich is hereby incorporated by reference.

A suture cutting blade 86 can be coupled to and/or held by the pusher52. Operation of the cutting blade 86 will be discussed in more detaillater in this specification. In other embodiments, the cutting blade 86may be a continuous extension of the pusher assembly 88, rather than aseparate part from the pusher 52. The pusher assembly 88 can be placedinto the proximal end 90 of the shaft 46 and into engagement with thecrimping member 64. As will be described later, the crimping member 64may include one or more blade steering guides (not easily visible inthis view) configured to restrict lateral movement of the suture cuttingblade 86 away from the direction substantially parallel to thelongitudinal axis of the shaft 46.

FIG. 5 is a perspective view of one embodiment of a crimping member 64having a hammer 48, an anvil 50, and an expanded receiving face 56. Thecrimping member 64 has first and second opposing legs 66, 68 which areconfigured to resiliently bias the hammer 48 and anvil 50 apart unlessurged together by the pusher (not shown in this view). In thisembodiment, the expanded receiving face 56 is an extension of the secondopposing leg 68, past where the anvil 50 is located. In otherembodiments, the extended receiving face 56 could be an extension of thehammer 48, for example in embodiments where the hammer 48 does not movewhile the anvil does. In still other embodiments, it is possible for theextended receiving face 56 to be separate from both the hammer 48 andthe anvil 50, but it is preferred to have the extended receiving face 56be an extension of the leg including the anvil 50 as shown in theembodiment of FIG. 5. The collar recess 60, the flexure portion 74, therecess 76, the opening 72 defined by the second leg 68, and the roundededge 58 of the expanded receiving face 56, all discussed previously, canbe seen in more detail the view of this embodiment.

FIG. 6 is a perspective view of one embodiment of a pusher 52 configuredto engage a hammer (not shown in this view). In this embodiment, asuture cutting blade 86 is coupled to the pusher 52. The pusher 52 caninclude a contoured notch 92 to help advance and retract the blade 86.Those skilled in the art will know a variety of ways a blade 86 could beattached to the pusher 52. The blade 86 can be configured to extendforward relative to the end of the pusher 52 so that the suture blade 86is in a position to cut suture ends after or just as the suture fasteneris crimped.

FIGS. 7,8, and 9 illustrate the operation of a surgical instrumentembodiment for crimping a suture fastener. FIGS. 7A and 8A illustrateadditional detail for this described operation. In particular, FIG. 7 isa partial cross-sectional side view of the embodied instrument forcrimping a suture fastener from FIG. 2 (and discussed above). A suture94 has been secured into one or more objects 96, 98 for example, atissue prosthetic valve sewing ring and underlying aortic annulartissue. The suture ends 100 have been passed through a suture fastener54 (crimpable sleeve) loaded into the expanded receiving face 56 on thedistal end 44 of the instrument. The suture ends 94 also pass throughthe openings 72, 70, defined by the second opposed leg 68 and the shaft46, respectively, and accordingly exit the bottom of the instrument.This loading of the suture 94 can be accomplished, for example, with asnare device, not shown, but known to those skilled in the art. FIG. 7Ais a non-cross-sectioned bottom view of the device and situation shownin FIG. 7.

The pusher 52 is resting on a portion of the first opposed leg 66 whichdoes not substantially force the hammer 48 into contact with the suturefastener 54. In other embodiments, the first opposed leg may include apre-load bump (not shown in this embodiment, but examples will be shownlater) which would cause the hammer to be pre-loaded lightly against thesuture fastener 54 in order to help hold it in place prior to crimping.The suture cutting blade 86 is positioned adjacent to the openings 70,72, but cannot cut the suture ends 100 at this point.

As shown in the partial cross-sectional side view of FIG. 8, the pusher52 has been advanced by an actuator (not shown) to a first positionwhere the hammer 48 is forced down onto the suture fastener 54, towardsthe anvil 50, resulting in a suture holding crimp being formed in thesuture fastener 54. Before the pusher 52 is advanced to the positionshown in FIG. 8, the expanded receiving face 56 can be moved intocontact with at least one of the one or more sutured objects 96, 98 astension is applied to the suture ends 100 to remove suture slack priorto crimping. When the pusher 52 has been advanced to the first positionshown in FIG. 8, the suture cutting blade 86 is also starting to crossthe openings 70, 72, but the suture ends 100 are not in a position to becut yet.

FIG. 8A is a cross-sectional view taken along line 8A-8A from FIG. 8,looking down the device shaft 46, and illustrating one embodiment ofblade steering guides 102 formed in the anvil 50. Since the anvil 50 iscoupled to or an extension of the second opposed leg 68, the bladesteering guides 102 could also be said to be formed in the second leg 68as well. The one or more blade steering guides 102 are configured tohelp restrict lateral movement of the suture cutting blade 86 away froma direction substantially parallel to the longitudinal axis of the shaft46.

FIG. 9 is a cross-sectional side view of the embodied instrument forcrimping a suture fastener from FIG. 8 with the pusher 52 advanced to asecond position where the blade 86 coupled to the pusher 52 has advancedto the point where it is able to cut the suture ends 100. Depending onthe configuration, the blade 86 can extend towards the distal end of thedevice far enough to cut the suture ends 100 without any assistance froma user of the device. In other embodiments, the blade 86 can extend tothe point where the suture ends 100 are pinched against the blade 86,and the user controls the moment when the suture cut is completed bypulling on the suture ends 100. When the pusher 52 is in this secondposition, the hammer 48 does not have to crimp the suture fastener 54further due to opposing surfaces 104 on the hammer 54 and anvil 50 whichcan be arranged to limit the hammer 48 motion.

As mentioned previously (for example, with regard to FIG. 5), someembodiments of an instrument for crimping a suture fastener to asurgical suture can include a crimping member having first and secondopposed legs 66, 68. In such embodiments, the hammer 48 may be locatednear the end of the first opposed leg 66, while the anvil 50 may belocated at the end of the second opposed leg. The first opposed leg 66may also include a flexure portion. The flexure flexes to allow thehammer 48 to be moved towards the anvil 50 by the pusher 52. FIGS.10A-10J illustrate different crimping members having a variety offlexure embodiments. For example, the embodiments of FIGS. 10A and 10Bhave a straight flexure 106 which is oriented to be substantiallyperpendicular to the expanded receiving face 56 when not being flexedunder a load. The embodiment of FIG. 10B also has a pre-load bump 108 onthe flexure 106. The pre-load bump 108 can be used in some embodimentsto provide a slight interference with the pusher (not shown here) beforethe pusher is advanced into contact with the hammer 48. This slightinterference can deflect the hammer 48 slightly against a suturefastener (not shown) held in the expanded receiving face 56 in order tokeep the fastener from falling out of the device prior to crimping.

FIG. 10C illustrates another embodiment of a crimping member having astraight flexure 110, however this straight flexure is not substantiallyperpendicular to the expanded receiving face 56 when not being flexedunder a load. The embodiment of FIG. 10C also includes a pre-load bump108, the features of which have been discussed above.

Some flexure embodiments will not be straight. As examples, the crimpingmember embodiments of FIGS. 10D and 10E include an arced flexure 112having a single bend in the flexure 112. The embodiment of FIG. 10E alsoincludes a pre-load bump 108, the features of which have been discussedabove. Other crimping member embodiments may have wavy flexures withmore than a single bend. For example, the crimping member embodiments ofFIGS. 10F-10I include a wavy flexure 114. The embodiment of FIG. 10Halso includes a pre-load bump 108, the features of which have beendiscussed above. Other flexure embodiments are possible, including, butnot limited to a hairpin flexure that doubles back on itself. Forexample, the crimping member embodiment of FIG. 10J includes a hairpinflexure 116. The embodiment of FIG. 10J also includes a pre-load bump108, the features of which have been discussed above.

The embodiments of a crimping instrument with reduced dimension andcompatibility with an existing, proven knot, which have been discussedabove, also have tissue protection features, such as the sharp edgeavoidance made possible by the expanded receiving face on smallerdimensioned devices. Other embodiments may include an additional tissueprotection feature, for example a rotatable shaft which enables anoperator to orient the direction of the crimped suture fastener toorient the direction of the suture tails away from delicate structures.As one example, FIG. 11 is a partially exposed perspective view of oneembodiment of an instrument 118 for crimping a suture fastener. Theinstrument 118 has a rotatable shaft 120 with a rotation knob 122coupled to the shaft 120 and configured to simultaneously rotate theshaft 120 and the push rod 140. The rotation knob 122 can have a varietyof shapes, and in some embodiments, the rotation knob 122 could be theshaft itself. In this embodiment, the rotation knob 122 also includes acrimp direction indicator 124 that correlates with a direction that thecrimps formed in a suture fastener will direct trimmed suture tails.Depending on the embodiment, the crimp direction indicator 124 couldpoint in a direction the suture tails will point. In other embodiments,the crimp direction indicator 124 could point in the opposite direction.In either case, or with any readily predictable correlation between thecrimp direction indicator 124 and the crimped fastener produced by theinstrument 118, the operator of the instrument 118 can readily orientthe device handle 126 and/or shaft rotation knob 122 to have the suturetails face a desired direction. This tissue protection feature can beespecially helpful when installing artificial heart valves, as it may bedesirable to have the crimped fasteners direct the suture tails awayfrom the valve so as not to have tissue or valve material contacting thecrimped fastener surface or the suture tails. Since it may not always bepossible or ergonomically practical for a surgeon to rotate the handle126 of the device, embodiments having a rotatable shaft 120 offer moreorientation flexibility to the surgeon, thereby enabling tissue andprosthetic protection.

An actuator lever 128 is pivotably coupled to the handle 126 at pivotpoint 130. A biasing spring 132 is coupled between the handle 126 andthe actuator 128, rotating the actuator 128 counterclockwise around thepivot point 130 until the actuator 128 contacts the handle 126 at stoppoint 134. The actuator 128 also has a socket 136 which receives a ballend 138 of push rod 140. FIG. 11A is a side cross-sectional view of theinstrument 118 from FIG. 11. Push rod 140 may be coupled to the pusher52 or continuous with the pusher 52 as shown in FIG. 11A. When theactuator 128 is in the resting position shown, the push rod 140 isretracted away from the distal end 44 of the shaft 120. In thisposition, as discussed above, the pusher 52 is not engaging the hammer48. However, if the actuator 128 is squeezed towards the handle 126, theactuator socket 136 will advance the push rod 140 (and therefore thepusher 52) towards the distal end 44, thereby enabling the pusher 52 toengage the hammer 48 as discussed above in order to crimp a suturefastener.

The rotation knob 122 has a portion 142 which extends into the handle126. The handle 126 can include structure to rotatably support thisportion 142 of the rotation knob 122. For clarity and visualization ofother structures, rotational supports are not shown, but those skilledin the art will clearly know that such supports may easily beincorporated. A portion of the rotation knob 122 may include one or morefacets 144 which can be sized to engage a constraint, here illustratedas an embodiment with an upper constraint 146A and a lower constraint146B. Those skilled in the art will recognize that facets may includebut are not limited to, such structures as recesses, bumps, and anglededges. For convenience, however, such structures and their equivalentswill simply be referred to herein as facets. A profile of the facets 144and the constraints 146A, 146B can be seen in the view of FIG. 11B,which is a cross-sectional view taken along line 11B-11B from FIG. 11A,looking from a location in the handle towards the distal end of thedevice. When a facet 144 is flat against the constraint 146A, 146B,rotation of the shaft 120 (to which the rotation knob 122 is coupled)will be resisted. However, the facets 144 (of the rotation knob 122)and/or the constraints 146A, 146B may be made from a flexible materialso that an external force applied to the rotation knob 122 can cause thefacets 144 and/or the constraint 146A, 146B to deflect or deform,allowing the shaft 120 to rotate until other facets 144 contact theconstraints 146A, 146B. The mating of the facets 144 with the constraint146A, 146B can be felt by the user, thereby enabling indexing of theshaft rotation positions. In the embodiment illustrated in FIG. 11B, therotation knob 122 has twelve facets, however other embodiments may havea different number and/or type of facets. Other embodiments may notinclude facets, but may be configured to include rotational resistanceso that the shaft does not rotate at undesired times.

The rotation knob 122 is coupled to the shaft 120. The push rod 140 isconfigured to be able to slide through the rotation knob 122 indirections parallel to the longitudinal axis of the shaft 120. In thisembodiment, the push rod 140 also has one or more keyed features 141which can slide longitudinally in a mating fashion within correspondingone or more slots 143 in the rotation knob 122. The one or more keyedfeatures 141 permit longitudinal movement of the push rod 140 forcrimping operations. When the rotation knob 122 is rotated, however, theone or more keyed features 141 engaged the corresponding one or moreslots 143 to rotationally couple the push rod 140 to the rotation knob122. In this way, since the rotation knob 122 is also coupled to theshaft 120, both the push rod 140 and the shaft 120 are rotated directlyby the rotation knob 122. In other embodiments, the rotation knob 122may only be rotationally coupled to the shaft 120. In such embodiments,when the knob 122 is rotated, the rotational force would have to betransferred to the push rod 140 via the crimping member and hammer inthe distal end of the shaft 120. While such an embodiment is possible,it is not ideal because of the larger stresses placed on the componentsin the distal end of the device.

The instrument 118 of FIG. 11 includes a rotation adapter (to bediscussed in more detail below) having a proximal journal 200 and adistal journal 202. While the handle 126 may include bushing surfaces(not shown) within which the journals 200, 202 can spin, this has beenshown to be a difficult proposition when the handle 126 material (ofwhich the bushings are made) and the journal 200, 202 material are thesame. The potential difficulty can arise because the handle 126 may beultrasonically welded together, and the welding process can cause thejournals 200, 202 to become stuck to the bushings made from the handle.As such, it has been discovered that bushings made from a differentmaterial than that of the journal surfaces is advantageous. FIGS. 12Aand 12B illustrate one embodiment of a proximal bushing 204 in bothclosed and open configurations, respectively. In the embodiment of FIGS.12A and 12B, the proximal bushing 204 is a clinch bushing, but otherembodiments can be a wide variety of bushing types, including, but notlimited to a solid bushing, a split bushing, and a flange bushing.

Likewise, FIG. 13 illustrates one embodiment of a distal bushing 206. Inthe embodiment of FIG. 13, the distal bushing 206 is a split bushing,but other embodiments can be a wide variety of bushing types, including,but not limited to a clinch bushing, a solid bushing, and a flangebushing.

FIGS. 14A and 14B illustrate another embodiment of a rotation constraint208 in both a closed and open view, respectively. Unlike the multi-piecerotation constraint 146A, 146B from FIG. 11, this constraint 208 is aone-piece clamshell type design.

FIG. 15 illustrates a minimally invasive surgical device 210, similar tothe instrument 118 of FIG. 11, but with a rotation adapter 212 having aslightly different effector direction indicator 214 (as opposed to therotation knob 122 of FIG. 11), with a proximal bushing 204 and a distalbushing 206 supporting corresponding journals on the rotation adapter212, and with rotation constraint 208 limiting free rotation in theabsence of a sufficient outside rotational force applied to the effectordirection indicator 214. The bushings 204, 206 and the rotationconstraint 208 prevent the rotation adapter 212 from coming into contactwith the handle 126. Therefore, the handle 126 and the rotation adapter212 may be made from the same material if desired, for example, ABSplastic, although other embodiments may utilize other materials. Therotation constraint 208 and the bushings 204, 206 may be made from adifferent material such as PBT, although other embodiments may utilizedifferent materials.

While the embodiment of FIG. 15 utilizes a separate proximal bushing204, distal bushing 206, and rotation constraint 208, it has beendiscovered that it is advantageous to have a rotation adapter receiverwhich integrates bushings with a rotation constraint in a manner whichrelieves stress from the rotation constraint. For example, FIG. 16Aillustrates one embodiment of an assembled rotation adapter receiver216. The rotation adapter receiver 216 has opposing beams 218, 220. Aproximal bushing 222 is coupled between the opposing beams 218, 220. Adistal bushing 224 is also coupled between the opposing beams 218, 220.In this embodiment, the proximal bushing 222 is a clinch bushing, whilethe distal bushing 224 is a split bushing. The rotation adapter receiver216 also has a rotation constraint 226 coupled between the opposingbeams 218, 220 and positioned between the proximal and distal bushings222, 224. In this embodiment, the rotation adapter receiver 216 of FIG.16A is constructed from two identical parts. In other embodiments, thecomponents which make up a rotation adapter receiver need not beidentical, however, if the parts are identical, then the manufacturingprocess is simplified.

The identical parts which make up the rotation adapter receiver 216 areshown separated in FIG. 16B. As can be seen clearly in FIG. 16B, theopposing beams define flexure voids 228 between the rotation constraint226 and the proximal bushing 222 and between the rotation constraint 226and the distal bushing 224. FIG. 17 illustrates an example of therotation adapter receiver 216 installed in the handle of a minimallyinvasive surgical suturing device in order to support a rotation adapter284, the features of which will be discussed later in thisspecification. The handle 126 of the suturing device may be molded toengage the opposing beams 218, 220 of the rotation adapter receiver 216so that it is held in place.

FIG. 18A illustrates another embodiment of an assembled rotation adapterreceiver 230. The rotation adapter receiver 230 has opposing beams 232,234. A proximal bushing 236 is coupled between the opposing beams 232,234. A distal bushing 238 is also coupled between the opposing beams232, 234. In this embodiment, both the proximal and distal bushings 236,238 are split bushings. The rotation adapter receiver 230 also has arotation constraint 240 coupled between the opposing beams 232, 234 andpositioned between the proximal and distal bushings 236, 238. In thisembodiment, the rotation adapter receiver 230 of FIG. 18A is constructedfrom two identical parts. In other embodiments, the components whichmake up a rotation adapter receiver need not be identical, however, asmentioned previously, if the parts are identical, then the manufacturingprocess is simplified.

The identical parts which make up the rotation adapter receiver 230 areshown separated in FIG. 18A. As can be seen clearly in FIG. 18B, theopposing beams define flexure voids 242 between the rotation constraint240 and the proximal bushing 236 and between the rotation constraint 240and the distal bushing 238. FIG. 19 illustrates an example of therotation adapter receiver 230 installed in the handle of a minimallyinvasive surgical suturing device in order to support a rotation adapter284, the features of which will be discussed later in thisspecification. The handle 126 of the suturing device may be molded toengage the opposing beams 232, 234 of the rotation adapter receiver 230so that it is held in place.

FIG. 20A illustrates another embodiment of an assembled rotation adapterreceiver 244. The rotation adapter receiver 244 has opposing beams 246,248. A proximal bushing 250 is coupled between the opposing beams 246,248. A distal bushing 252 is also coupled between the opposing beams246, 248. In this embodiment, both the proximal and distal bushings 250,252 are clinch bushings. The rotation adapter receiver 244 also has arotation constraint 254 coupled between the opposing beams 246, 248 andpositioned between the proximal and distal bushings 250, 252. Therotation adapter receiver 244 of FIG. 20A is constructed from twoidentical parts. In other embodiments, the components which make up arotation adapter receiver need not be identical, however, if the partsare identical, as mentioned previously, then the manufacturing processis simplified.

The identical parts which make up the rotation adapter receiver 244 areshown separated in FIG. 20B. As can be seen clearly in FIG. 20B, theopposing beams define flexure voids 256 between the rotation constraint254 and the proximal bushing 250 and between the rotation constraint 254and the distal bushing 252. FIG. 21 illustrates an example of therotation adapter receiver 244 installed in the handle of a minimallyinvasive surgical suturing device in order to support a rotation adapter284, the features of which will be discussed later in thisspecification. The handle 126 of the suturing device may be molded toengage the opposing beams 246, 248 of the rotation adapter receiver 244so that it is held in place.

FIGS. 22A and 22B illustrate a schematic cross-sectional view of arotation constraint 258 (of a rotation adapter receiver) and therotation index 260 (of a rotation adapter) in both a resting state and atransitory state between two resting positions, respectively. In thetransitory state of FIG. 22B, the apex 262 between adjacent facets ofthe rotation index 260 causes the rotation constraint 258 to deform. Therotation constraint 258 should be constructed from a material which willendure this deformation while being able to transition back to itsundeformed state when the rotation is completed.

As mentioned earlier, it has been found that it is advantageous to havea rotation adapter receiver which integrates bushings with a rotationconstraint in a manner which relieves stress from the rotationconstraint. FIG. 23 illustrates how one of the present embodiments andits equivalents accomplish this additional benefit. FIG. 23 is across-sectional perspective view of one embodiment of a rotation adapterreceiver 230 with the rotation index 260 of a rotation adapter visiblewithin the rotation constraint 240. Without being tied to one specifictheory, modelling suggests that the deformation stress imparted into therotation constraint 240 (the deformation stress being denoted withshading) is somewhat dissipated into the opposing beams 232, 234, andespecially attenuated in the area of the beams near the flexure voids242. This may enable a greater choice of materials than a designfeaturing a rotational constraint which is separate from bushings and/orwhich does not include one or more opposing beams.

As noted above, a rotation adapter can work in conjunction with arotation adapter receiver. FIG. 24 illustrates one embodiment of arotation adapter 264, in this case for use with a minimally invasivesurgical apparatus for applying surgical knots. The rotation adapter 264has a proximal journal 266 and a distal journal 268. The proximaljournal 266 is configured to spin within a proximal bushing, while thedistal journal 268 is configured to spin within a distal bushing. Therotation adapter 264 also has a rotation index 270 coupled between theproximal and distal journals 266, 268. The rotation adapter 264 furtherhas an actuator input 272 (in this embodiment a keyed slot) and aneffector output 274. This embodiment also has an effector directionindicator 276, which functions like the rotation knob discussed above.

As illustrated in the exploded view of FIG. 25, a shaft 278 may becoupled to the effector output 274 of the rotation adapter 264. Anactuator rod/pusher 280 may be inserted into the actuator input 272 ofthe rotation adapter 264. The pusher 280 may extend through the shaft278 and into operational contact with a hammer/anvil 282 for crimpingmechanical knots. In this embodiment, the actuator input 272 is keyed sothat rotation of the effector direction indicator 276 not only rotatesthe shaft 278, but also the actuator rod/pusher 280. The keyed actuatorinput 272 allows rotation of the rotation adapter 264 to rotate theactuator rod/pusher 280 while the actuator rod/pusher 280 is free toslide axially within the rotation adapter. The rotation adapter 264 fitswithin the halves of the rotation adapter receiver 230.

FIG. 26 illustrates another embodiment of a rotation adapter 284, inthis case, for use with a minimally invasive surgical apparatus forsuture stitching. The rotation adapter 284 has a proximal journal 286and a distal journal 288. The proximal journal 286 is configured to spinwithin a proximal bushing, while the distal journal 288 is configured tospin within a distal bushing. The rotation adapter 284 also has arotation index 290 coupled between the proximal and distal journals 286,288. The rotation adapter 264 further has an actuator input 292 (in thisembodiment for receiving a needle twisting barrel) and an effectoroutput 294. This embodiment also has an effector direction indicator296. The effector direction indicator 296 functions like the rotationknob and the direction indicator 276 discussed above, however thisdirection indicator 296 also includes a suture management feature 298through which a suture end may be threaded so that the suture followsthe rotation of the end effector from which it comes, thereby helping toprevent suture tangling as the end effector is rotated. The actuatorinput 292 also includes a cam spring 300 that will be discussed in moredetail with the following figure.

As illustrated in the exploded view of FIG. 27, a shaft 302 may becoupled to the effector output 294 of the rotation adapter 284. Asuturing tip 304 with a tissue bite area and a ferrule holder (known tothose skilled in the art) may be located at the distal end of the shaft302. A needle 306 passes through and is coupled to a needle twistingbarrel 308. The barrel 308 has cam paths 310 which are engaged by a cam312 biased against the barrel 308 by a cam spring 300 when the barrel308 is placed into the actuator input 292 of the rotation adapter 284.An actuator (not shown) coupled to the proximal end 314 of the needle306 moves the barrel axially back and forth within the actuator input292. The interference of the cam 312 with the cam path 310 causes theneedle to rotate 90 degrees every time the needle is pulled back in aproximal direction. This rotation of the needle facilitates a runningstitch as is known to those skilled in the art, and as will be furtherexplained below. The proximal and distal journals 286, 288 ride withinthe proximal and distal bushings 236, 238 of the rotation adapterreceiver 230. When the effector direction indicator 296 is rotated, therotation adapter rotates, causing the coupled shaft 302 also to rotate.The engagement of the cam 312 with the sides of the cam path 310 of thebarrel 308 also causes the needle barrel 308 to correspondingly rotate.Thus, the relationship of the needle 306 to the suturing tip 304 ispreserved, even when the direction indicator 296 is used to rotate theshaft 302 and the device tip 304.

FIG. 28 is an assembled perspective view of the rotation adapterreceiver 230 and the rotation adapter 284 from FIG. 27. shownschematically as part of a minimally invasive surgical suturing device314. As mentioned previously, the suturing device 314 may have asuturing tip 304 which defines a tissue bite area 316. The tip 304 mayalso define a ferrule receiver 318. A suture 320 with a ferrule 322attached to a first end of the suture may be used in conjunction withthe suturing device 314. The ferrule 322 may be loaded into the ferruleholder 318, and an opposite end of the suture 320 may be threadedthrough the suture management feature 298 on the direction indicator296.

FIGS. 29A-29G illustrate how the suturing device is used to advance theneedle 306 through tissue and across the tissue bite area 316 to pick upthe ferrule 322 so that the ferrule (and its attached suture) may bepulled back through the tissue and then the process repeated. FIGS.29A-29G are partial cross-sectional side views of the suturing device ofFIG. 28 taken along line 29-29.

As shown in FIG. 29A, the needle 306 passes through and is coupled tothe needle twisting barrel 308. The barrel 308 has cam paths 310 whichare engaged by cam 312. Cam 312 is biased against the barrel 308 by camspring 300. A proximal end 314 of the needle 306 is coupled to anactuator (not shown). The actuator is capable of selectively moving theneedle 306 (and therefore, also the barrel 308 to which it is attached)axially back and forth within the actuator input 292 if the rotationadapter 284. As illustrated in FIG. 29A, the needle 306 is in aretracted position where the tip 324 of the needle 306 is housed withinthe suturing tip 304 and has not passed through the tissue bite area316. The ferrule 322, coupled to the suture 320, is loaded within theferrule holder 318 on the distal side of the tissue bite area 316 in thesuturing tip 304.

As illustrated in FIG. 29B, the device may be positioned so that tissue326 is within the tissue bite area 316. As shown in FIG. 29C, theactuator (not shown) may move the needle 306 in a distal direction 328,such that the needle tip 324 passes through the tissue 326 in the tissuebite area 316, past a spring 330 that rides on the needle 306, and intoan interference fit with the ferrule 322.

As illustrated in FIG. 29D, the actuator (not shown) may move the needle306 in a proximal direction 332, such that the needle tip 324, theferrule 322 which is coupled to it, and a portion of the suture 320coupled to the ferrule 322 pass back through the tissue 326. As thisproximal movement 332 of the needle 306 begins, the needle tip 324 isoriented as shown in FIG. 29C. In this orientation, there is not enoughgap between the outer surface of the needle 306 and the ferrule 322 toallow the spring 330 to remove the ferrule 322 from the needle 306.Recall, however, that the barrel 308 is coupled to the needle 306. Thebarrel 308 has cam paths 310, and the rotation adapter 284 has a spring300 which biases a cam 312 against the barrel 308 so that the cam 312rides within the cam paths. The cam paths 310 are configured so that thebarrel 308 (and therefore, the needle 306) does not rotate when theneedle is moved in a distal direction. However, when the needle is movedproximally 332 as shown in FIG. 29D, the interference between the cam312 and the cam paths 310 cause the barrel 308 (and therefore the needle306) to rotate 334 ninety degrees to the position shown in FIG. 29D. Theneedle tip 324 has a more tapered profile where it mates with theferrule 322 as shown in the view of FIG. 29D.

As illustrated in FIG. 29E, the suturing device may be lifted 336 so thetissue 326 is no longer in the tissue bite area 316. As illustrated inFIG. 29F, the needle 306 may be moved in a distal direction 328 so thatthe needle tip 324 passes through the tissue bite area and past thespring 330 that rides on the needle 306 such that the ferrule 322 ispositioned again within the ferrule holder 318. Since the needle tip 324offers a longer taper to the spring 330 in the orientation of FIG. 29F,the spring 330 pushes the ferrule 322 off of the needle tip 324 as theneedle 306 is moved in a proximal direction 332 as shown in FIG. 29G. Asshown in FIG. 29G, the cam 312 has again caused barrel 308 (andtherefore needle 306) to rotate 334 ninety degrees as the needle306/barrel 308 are moved proximally. The cam paths 110 are configured sothat the rotation occurs after the ferrule 322 has been stripped fromthe needle tip 324. The device of FIG. 29G is now in the sameconfiguration as that of FIG. 29A, and the process of FIGS. 29A-29G maybe repeated as desired to place multiple stitches of the suture 320.

In the embodiments discussed herein previously, it has been mentionedthat some embodiments of a surgical suturing device having a rotationadapter may include a suture management feature 298 as part of thedirection indicator 296. Such a direction indicator 296 is shown on asample surgical suturing device 338 in FIG. 30A. In this example, thesurgical suturing device 338 has two needles (not visible in this view)which can traverse the tissue bite area 340 in a manner similar to thatunderstood by those skilled in the art. First and second ferrules (notvisible in this view) are coupled to the ends of a suture 342. Theferrules are held within ferrule holders 344, and the suture 342 can bewrapped around the back of the distal tip 346. In this embodiment, theshaft 348 also has a suture management feature 350 through which thesuture 342 may be threaded. If the suture is long enough, the suture 342may also be threaded through the suture management feature 298 on thedirection indicator.

In the embodiment of FIG. 30A, the suture management features 298, 350are holes through which the suture 342 must be threaded. In otherembodiments, the suture management features may have othercharacteristics. For example, in the embodiment of FIG. 30B, the suturemanagement features 352 and 354 of another surgical suturing device 356are slotted to be able to receive a tube 358 in which the suture 342 hasbeen pre-loaded. This allows the tube 358 to be snapped quickly into thesuture management features 352, 354 rather than having to take the timeto thread the suture.

FIG. 31 illustrates another embodiment of a direction indicator 360.This direction indicator 360 has yet another suture management feature362. In this embodiment, a tortuous path 364 leads to the suturemanagement feature so that a suture may more easily be worked into thesuture management feature 362 than simple threading. Any middle portionof a suture can be placed into the tortuous path 364 and worked back andforth along the path until the suture reaches the suture managementfeature 362.

Various advantages of a rotation adapter and rotation adapter receiverhave been discussed above. Embodiments discussed herein have beendescribed by way of example in this specification. It will be apparentto those skilled in the art that the forgoing detailed disclosure isintended to be presented by way of example only, and is not limiting.Various alterations, improvements, and modifications will occur and areintended to those skilled in the art, though not expressly statedherein. These alterations, improvements, and modifications are intendedto be suggested hereby, and are within the spirit and the scope of theclaimed invention. Additionally, the recited order of processingelements or sequences, or the use of numbers, letters, or otherdesignations therefore, is not intended to limit the claims to anyorder, except as may be specified in the claims. Accordingly, theinvention is limited only by the following claims and equivalentsthereto.

What is claimed is:
 1. A rotation adapter for a minimally invasivesurgical apparatus, the rotation adapter comprising: a proximal journal;a distal journal; a rotation index coupled between the proximal journaland the distal journal; an actuator input, wherein the actuator inputcomprises a keyed slot; and an effector output.